Azithromycin for sarcoidosis
Research type
Research Study
Full title
A single arm, open-label clinical trial of azithromycin in pulmonary sarcoidosis
IRAS ID
260086
Contact name
Simon Hart
Contact email
Sponsor organisation
Hull University Teaching Hospitals NHS Trust
Eudract number
2019-000580-24
Duration of Study in the UK
0 years, 9 months, 29 days
Research summary
Patients with sarcoidosis need treatment options that improve their disease without causing unacceptable side effects. We know that in sarcoidosis the body’s immune system becomes hyper-active, and recent studies have suggested this is driven by over-activity of the mTOR (mechanistic target of rapamycin) pathway that signals inside cells to control the immune system. Azithromycin is an antibiotic that interferes with mTOR signalling and has immune-modulating and anti-bacterial effects, both plausible beneficial properties in sarcoidosis. Azithromycin is readily available and cheap, and long term treatment has been shown to be safe in other chronic diseases.
In our open-label cohort study, 20-30 patients with pulmonary sarcoidosis will receive azithromycin (one 250 mg tablet once daily) or usual care for 3 months. Assessments will be performed at baseline and 1 and 3 months to assess treatment response. We will measure cough, quality of life, and standard clinical measurements. Blood samples will be taken for immunological biomarkers to see how the over-active blood cells respond to azithromycin treatment.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0100
Date of REC Opinion
17 May 2019
REC opinion
Further Information Favourable Opinion